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Associate Director, Biostatistics

  • Job type: Permanent
  • Location: San Francisco, California
  • Salary: US$150000 - US$200000 per annum
  • Job reference: 184624/003_1533742858
  • Sector: Biostatistics, EPM Scientific
  • Date posted: 08/08/2018

Do you have experience with late-stage clinical trials and have a passion for providing life changing treatments to patients with debilitating diseases? A leader in, developing small molecule drugs to treat neurodegenerative diseases is looking to add an Associate Director, Biostatistics to their growing Biometrics group that will play a key role in strategic planning and develop optimal clinical development plans with cross-functional drug development teams

Associate Director, Biostatistics will be responsible for:

  • Writing statistical methodology section of the protocol and statistical analysis plans

  • Plan regulatory filings and ensure a timely submission with efficiency and accuracy in regulatory filing activities

  • Direct the activities of internal and external statistical programmers

  • Review eCRFs and edit checks documents

  • Support and participate in the preparation of study reports, regulatory submissions, and annual IND safety update reports

Associate Director, Biostatistics should have:

  • Ph.D. in statistics or biostatistics

  • At least 6-10 years of biopharmaceutical statistics experience

  • Experience in late stage drug development, including phase IIb, phase III, and submissions in the pharmaceutical industry

  • Ability to communicate effectively within cross functional project teams

  • Experience in organising regulatory submissions such as BLA, NDA, sNDA, and MAA submissions.

  • Good working knowledge of ICH, FDA and GCP regulations and guidelines

  • Experience in Cardiology or Neurology

Work Perks:

  • We seek to provide industry leading benefits to our employees to promote a healthy

  • lifestyle, work-life balance, and financial stability.

  • We provide generous PTO, Reimbursements for Athletic memberships, and Tuition assistance.